I've submitted my IRB application! What happens next?
The IRB Chair will review your proposal and evaluate its risk level. Every case is different, but in general the IRB Chair and IRB staff will contact you by email with our response. Zero to low-risk proposals generally get a response within one week, and moderate risk proposals usually take two weeks. High-risk proposals require full Board review, which only happens monthly during the academic calendar year. If the IRB Chair requests changes to your methods, documentation, or other items, you do not need to submit a new proposal—simply respond to the IRB email with answers to our questions, attaching updated documents as necessary.
If the IRB requests changes to my proposed research plan, do I need to submit a new proposal?
No, just respond to the emails you receive from the IRB Chair and IRB staff
How long does IRB approval take?
The approval process can take several weeks, depending on whether you meet the submission deadline, the complexity of your project, the subjects you intend to work with, the completeness of your application materials, and other factors. Plan to submit your application at least three weeks before you want to start your research.
Why does the College need to have an IRB?
Institutional Review Boards were a response to a disturbing series of terrible crimes committed against vulnerable populations in the name of scientific investigation, particularly in the 20th century. The most notorious examples are the Nazi experiments that came to light in the Nuremberg Trials, and one product of those post-war investigations was a code of professional behavior (The Nuremberg Code) that remains foundational to the ethics of research on human beings.
Equally disturbing cases in the U.S. (e.g., The Tuskegee Syphilis Experiments) led the federal government in the early 1970s to develop standards for proper treatment of human research subjects, and to require research institutions to comply with those standards. Establishing an IRB to oversee ethical compliance is one of those requirements. IRBs remain important as additional sets of eyes to evaluate research plans for safety and protection of rights, concerns that can be overlooked in a researcher's enthusiasm for his or her work.
Am I doing research on human subjects?
Please see Must I apply? if your research involves interaction with other human beings or working with restricted data sets about human subjects. But if you still are uncertain about whether it meets the definitions on this page, please contact the IRB! A quick email may be all it takes to determine whether or not you need to seek IRB approval.
I don’t plan to ignore my research subjects’ untreated syphilis or to do experimental lobotomies on mentally ill patients. Why do I need IRB approval?
The IRB is meant to protect human subjects from all kinds of potential harm, not just physical. Most research at Middlebury College won't expose subjects to the kinds of harm notorious in those infamous historical cases. But many of our research agendas might expose subjects to psychological, emotional, or (occasionally) physical risks about which they ought to be informed and to which they normally ought to be able to consent.
What do I have to do to get IRB approval of my research?
Fill out the IRB's application form, describing what you intend to do, the subject pool you intend to work with, and the measures you intend to employ to obtain informed consent and protect subjects' privacy. You'll also need to take an online course on the ethics of research on human beings. This course takes roughly three hours to complete. After you take the tutorial and pass the quiz, the site will provide a certificate of completion for you. Please save this form as a PDF, JPEG, or GIF and submit it with your protocol.
How do I get blanket IRB approval for the course I am teaching?
Courses in which the curriculum consists substantially of independent student research are subject to IRB approval. Faculty members seeking approval for a course must submit an application for the course.
What is the deadline for submitting my application?
Why haven’t I ever heard of the IRB before?
Traditionally IRBs dealt with research in the "hard" sciences and some social sciences, because other disciplines rarely involved human subjects in their research. That's changing, however, and human subjects—and therefore IRBs—are more frequently a part of research in the humanities. One recent example of the expansion of IRB concerns at Middlebury College beyond the hard sciences: a couple of years ago, a senior English major developed a research project on Dr. Seuss books, and in the process wanted to read one of his books to elementary school children and gauge their reactions. In this case, though, the Dr. Seuss book happened to be about nuclear holocaust, and the IRB was concerned enough about the emotional effect on the children that it required parental permission for the researcher to work with the elementary school class.
Where can I find more information?
My project was approved! Now what?
As Principal Investigator, you have a few ongoing responsibilities to the IRB. You must:
- notify the IRB if you want to change your research methods or location during the one-year approval period
- apply for an extension if you need a bit more time than one calendar year to complete your project
- apply for renewal if your project will run for another year
- submit a status report for your project to date if you want to renew or extend a project beyond the one-year approval period
- keep all documentation related to the project, including signed consent forms, for at least four years from the approval date (if you are a student, arrange this with your advisor)
- keep any publications resulting from your research for at least four years from the approval date (if you are a student, arrange this with your advisor)
Can I use Amazon Mechanical Turk (MTurk) for online data collection?
MTurk serves as a front-end that can connect researchers to prospective research participants. However, it is important to know that MTurk was not specifically designed with social science research in mind, which has implications for participants’ privacy. Recent research shows that MTurk worker IDs can be linked to individual Amazon profiles including wish lists and previous product reviews. This means that researchers must be careful in deciding what information to collect from participants; MTurk worker IDs should not be collected unless necessary. Projects where no identifying information, such as worker ID, is collected from participants can be considered for Level I review. If it is necessary to collect worker IDs, then the researchers should ensure that worker IDs are kept confidential and secure, are not linked back to survey data, and are deleted after use.
Additionally, data collected using the Amazon Mechanical Turk data collection tool resides on the Amazon servers and no assurance can be made as to its use for purposes other than the research. Researchers are advised to therefore collect data using third party survey software, such as Qualtrics, with known policies for data security and anonymity. This should be reflected in the consent information given to participants, such as:
"Amazon will maintain a record of your participation, and its use of this information is governed by the privacy agreement that you signed with Amazon. For more information, please refer to Amazon’s MTurk privacy notice available at https://www.mturk.com/mturk/privacynotice.”
I’m a researcher at another university and would like to include Middlebury students/faculty/staff in my subject pool. Do I need to go through the Middlebury IRB?
If you do not yet have IRB approval from your home institution, then it is appropriate for the Middlebury IRB to be the reviewing body of record. Please submit your project for Middlebury IRB approval. If you have already submitted to your own institution’s IRB, the process should be much more streamlined. We require copies of the IRB application and approval from your home institution and documentation of human research protection training for you and all project personnel (defined as anyone materially involved in the conduct or analysis of the study). We accept NIH or current CITI training completed within the last five years. After reviewing these documents we will let you know whether it will be possible to sign an authorization agreement with your home institution, whether modifications will be required, etc. Finally, please note that an approval from our IRB (or a determination that our review is not required) does not reflect a blanket endorsement for a specific research project conducted at Middlebury.
I’m not collecting data or interacting with people, but I’m using a secondary/restricted dataset. Do I need IRB approval?
It depends on what kind of information about participants you are obtaining and how you acquire access to the dataset.
Publicly Available Secondary Datasets: Research projects involving only analysis of secondary data that either never contained, or have been stripped of identifiers (e.g. names, address, etc.) and are publicly available do not require prior IRB approval because their use is not considered research involving human subjects under the federal Common Rule, 45 CFR Part 46. With public datasets, neither the Middlebury researcher nor any collaborating researcher on the project(s) has access to links that would connect these data to the individuals from whom they were derived. Some example sources of public use survey data include: US Bureau of the Census, Bureau of Labor Statistics, and National Election Studies.
Restricted datasets: If the data set(s) are available to researchers and others, but the data holder requires a “responsible use statement” or similar data security agreement to ensure appropriate use and protection of the data, then please submit the project for Level I review. Include copies of data use agreements. In such a case, neither the Middlebury researcher nor any collaborating researcher on the project is able to connect the data to the individuals from whom they were derived. No researcher on the project may attempt to re-identify any person from whom the data were derived. In the latter case, the researcher should submit a copy (signed, if necessary) of the data security agreement required by the institution responsible for the dataset agreeing not to make any attempt at re-identifying participants.
If, however, you are obtaining a dataset(s) that contains direct (e.g., name, address, birthdate, Social Security number, email address, etc.) or indirect (e.g., data that may be combined to readily identify an individual, such as exact GPS coordinates of someone’s house) identifiers, you need to obtain IRB approval before conducting the research. Depending on how sensitive these data are, Level II or Level III approval may be required. Again, the IRB will need a (signed) copy of the data security agreement required by the institution responsible for the dataset.
Any questions regarding whether a data set meets these requirements should be referred to the IRB.